Auto-PAP Therapy For Improved Fetal Growth

University of Michigan43 enrolled

Overview

The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea Pregnancy

Interventions

Auto-PAPDEVICE

Women will be using the Auto-PAP device nightly from randomization to end of pregnancy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least 18 years old; * no more than 20 weeks pregnant; * pregnant with one baby; * found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study. Exclusion Criteria: * more than 20 weeks pregnant; * pregnant with twins, triplets, or more babies; * a current smoker, drink alcohol, or use recreational drugs; * currently using positive-airway pressure therapy for treatment of obstructive sleep apnea; * diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.

Locations (1)

University of Michigan Heath System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester

A slowing of fetal growth will be defined as a slowing of fetal growth by \>=33% during the last trimester

Time frame: 3rd trimester

Secondary Outcomes

Presence or Absence of Placental Hypoxia

The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia

Time frame: At delivery the placenta will be collected and processed.

Data from ClinicalTrials.gov

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